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Anticoagulant

Apixaban for Blood Clot (ASTRO-APS Trial)

Phase 4

Waitlist Available

Led By Scott C Woller, MD

Research Sponsored by Scott C. Woller, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from time of first dose of study drug through 2 days after receiving the last dose of study drug at the end of 12 months of treatment

Awards & highlights

ASTRO-APS Trial Summary

This trial is comparing two blood thinners, apixaban and warfarin, to see which is better at preventing blood clots in patients with a higher than average risk.

Eligible Conditions

Blood Clot
Antiphospholipid Syndrome

ASTRO-APS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of first dose of study drug through 2 days after receiving the last dose of study drug at the end of 12 months of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from time of first dose of study drug through 2 days after receiving the last dose of study drug at the end of 12 months of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of first dose of study drug through 2 days after receiving the last dose of study drug at the end of 12 months of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate (number divided by duration) of clinically overt thromboses (arterial and/or venous) or vascular death

Rate (number divided by duration) of occurrence of major (including fatal) and clinically relevant non-major bleeding

Secondary outcome measures

Net clinical benefit (combination of occurrence of thrombosis and bleeding rates)

Side effects data

From 2018 Phase 4 trial • 557 Patients • NCT01884337

Incision site pain

100%

80%

60%

40%

20%

Study treatment Arm

TOTAL KNEE REPLACEMENT (TKR)

TOTAL HIP REPLACEMENT (THR)

ASTRO-APS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ApixabanExperimental Treatment1 Intervention

Subjects will receive apixaban 5 mg tablets taken twice daily for the duration of the study.

Group II: WarfarinActive Control1 Intervention

Subjects will receive warfarin for the duration of the study, with the dose and frequency adjusted per clinician discretion to achieve an INR (International Normalized Ratio) between 2 and 4.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Apixaban

FDA approved

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